GLUCAGON kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

glucagon (UNII: 76LA80IG2G) (glucagon - UNII:76LA80IG2G)

Available from:

Eli Lilly and Company

INN (International Name):

glucagon

Composition:

glucagon 1 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. Glucagon for Injection is contraindicated in patients with: - Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warning and Precautions (5.1)] - Insulinoma because of the risk of hypoglycemia [see Warning and Precautions (5.2)] - Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warning and Precautions (5.3)] - Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia [see Warnings and Precautions (5.8)] Risk Summary Available data from case reports and a small number of observational st

Product summary:

Glucagon Emergency Kit for Low Blood Sugar contains 1 mg Glucagon for Injection (a lyophilized white to off-white powder) in a single-dose vial and 1 prefilled syringe containing 1 mL of diluent of Glucagon. Before Reconstitution: Store Glucagon for Injection at 68°F to 77°F (20°C to 25°C). Do not use Glucagon for Injection if the expiration date has passed. Do not freeze. Keep in its original package and away from light. After Reconstitution: Use reconstituted Glucagon for Injection immediately. Discard unused portion [see Dosage and Administration (2.3)].

Authorization status:

New Drug Application

Summary of Product characteristics

GLUCAGON- GLUCAGON
ELI LILLY AND COMPANY
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLUCAGON FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GLUCAGON FOR
INJECTION.
GLUCAGON FOR INJECTION, FOR SUBCUTANEOUS, INTRAMUSCULAR, OR
INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1960
INDICATIONS AND USAGE
GLUCAGON for Injection is an antihypoglycemic agent and a
gastrointestinal motility inhibitor indicated:
for the treatment of severe hypoglycemia in pediatric and adult
patients with diabetes. (1.1)
as a diagnostic aid for use during radiologic examinations to
temporarily inhibit movement of the
gastrointestinal tract in adult patients. (1.2)
DOSAGE AND ADMINISTRATION
Dosage in adult and pediatric patients to treat severe hypoglycemia
(2.2)
Adults and Pediatric Patients Weighing 20 kg or More:
The recommended dosage is 1 mg (1 mL) injected subcutaneously or
intramuscularly into the upper
arm, thigh, or buttocks, or intravenously.
If there has been no response after 15 minutes, an additional 1 mg
dose (1 mL) may be
administered while waiting for emergency assistance.
Pediatric Patients Weighing Less Than 20 kg:
The recommended dosage is 0.5 mg (0.5 mL) or dose equivalent to 20 to
30 mcg/kg injected
subcutaneously or intramuscularly into the upper arm, thigh, or
buttocks, or intravenously.
If there has been no response after 15 minutes, an additional 0.5 mg
dose (0.5 mL) may be
administered while waiting for emergency assistance.
Important Administration Instructions for Using Glucagon for Injection
to Treat Severe Hypoglycemia (2.1)
Glucagon for Injection is for subcutaneous, intramuscular, or
intravenous injection. Administer
intravenously ONLY under medical supervision.
See the Full Prescribing Information for administration instructions
Dosage in Adults for Using Glucagon for Injection as a Diagnostic Aid
(2.4)
Doses required for relaxation of the stomach, duodenum, and small
bowel, depend on the onset and
duration of effect re